Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Lehfilcon A contact lenses
Device: Comfilcon A contact lenses
Device: CLEAR CARE

Registration Number: NCT04980456

Lead Sponsor: Alcon Research

Brief Summary: The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.

Detailed Description: Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 257

Inclusion Criteria

Able to understand and sign an approved Informed Consent form;
Willing and able to attend all scheduled study visits as required by the protocol;
Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
Willing to stop wearing habitual contact lenses for the duration of study participation.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
Other protocol-defined exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofinity, then TOTAL30	CLEAR CARE	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
TOTAL30, then Biofinity	Lehfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Biofinity, then TOTAL30	Comfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
TOTAL30, then Biofinity	CLEAR CARE	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
Biofinity, then TOTAL30	Lehfilcon A contact lenses	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.
TOTAL30, then Biofinity	Comfilcon A contact lenses	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance VA (logMAR) With Study Lenses	Day 30, each study product	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (14): Alcon Investigator 8135
🇺🇸
Los Angeles, California, United States
Alcon Investigator 8062
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Oakland, California, United States
Alcon Investigator 6356
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Longwood, Florida, United States
Alcon Investigator 6565
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Maitland, Florida, United States
Alcon Investigator 6654
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West Palm Beach, Florida, United States
Alcon Investigator 6567
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Pittsburg, Kansas, United States
Alcon Investigator 8097
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Sterling Heights, Michigan, United States
Alcon Investigator 7980
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Willmar, Minnesota, United States
Alcon Investigator 8130
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New York, New York, United States
Alcon Investigator 6401
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Warwick, Rhode Island, United States
Alcon Investigator 6353
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Memphis, Tennessee, United States
Alcon Investigator 8106
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San Francisco, California, United States
Alcon Investigator 8175
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Austin, Texas, United States
Alcon Investigator 5582
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Louisville, Kentucky, United States